Reports of teenagers’ pharm parties, Rush Limbaugh’s OxyContin addiction, and the questions surrounding Michael Jackson’s death have kept prescription-drug abuse in the public eye. By requiring manufacturers of opioid drugs to create risk evaluation and mitigation strategies, the US Food and Drug Administration is seeking to reduce opportunities for drug abuse while keeping the therapies available to patients who need them. One pharmaceutical company suggests that, in addition to regulatory solutions, drug abuse could be curbed using drug-delivery strategies. Read more »

My colleague Erik Greb wrote an interesting blog post yesterday about new drug delivery technology reminiscent of childhood games. Games have changed dramatically, but the concept of using them to help educate applies today. Take for example, the problem of patient compliance. A video game called “Re-Mission” (HopeLab) is helping children and teens to “blast away” cancer cells (at least on screen). The point is that it empowers the young patient to take control, which unfortunately is not the case with many adult patients with cancer. Read more »

Relationship building and the benefit of deepening collaborative business models between excipient manufacturers and pharmaceutical companies in support of formulation development and manufacturing in a quality-by-design (QbD) paradigm and enhancing supply-chain practices was a key takeaway from ExcipientFest Americas, which was held in San Juan, Puerto Rico, this week. ExcipientFest Americas is operated by the Drug, Chemical and Associated Technologies Association (DCAT). ExcipientFest Americas is an exhibition and educational program that addresses technical considerations in excipient selection and formulation development as well as sourcing and supply-chain issues for excipients. Read more »

When faced with determined opponents, sports teams sometimes work the referees to win the game. A victory based on an interpretation of the rules is a victory nonetheless. The team of Warner Chilcott (Rockaway, NJ), Medicis Pharmaceutical (Scottsdale, AZ), Roche (Basel), and Stiefel Laboratories (Coral Gables, FL) recently used this tactic in their competition with generic drugmakers. The companies filed citizen petitions with the US Food and Drug Administration in an attempt to delay the approval of generic versions of their antibiotics. Read more »

It is inspiring to read news about the advancements being made in the fight against viral infections, including those against influenza and HIV. However, as comments to recent blog posts have reminded me, the struggle to develop antiviral therapies is highly complicated because viruses have the infamous tendency to mutate and adapt in their fight for survival and conquest of healthy cells. A major part of formulating and developing antivirals is trying to get some handle on a virus’s unpredictable nature, how it will change, and how these modified forms will strengthen our understanding of its interworkings. Read more »

I remember clearly receiving the warning from my child’s pediatrician regarding claims possibly linking the measles, mumps, and rubella (MMR) vaccine and autism. I also recall my pediatrician, herself a new mother, saying she was going to wait for further evidence before allowing her child to be administered the vaccine. That was eight years ago. Has the question regarding the possible link between the MMR vaccine and autism finally been answered? Read more »

At this year’s AAPS Annual Meeting and Exposition, Pharmaceutical Technology editors conducted video interviews with industry leaders recorded live at PharmTech’s booth on the exhibit floor. Click on the titles below to watch the vidcasts.

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Pharmaceutical Technology took a step into the future with our first Vidcast series from the annual meeting and exposition of the American Association of Pharmaceutical Scientists (AAPS) in Atlanta this week. In doing so, I had the opportunity to discuss the future of drug delivery and formulation with leading experts. Read more »

Researchers at the National Institute of Standards and Technology (NIST) have developed a method for evaluating the stability of protein-based formulations for storage at room temperature, opening the possibility of making this process quicker and less expensive. The researchers presented their findings at the American Chemistry Society’s National Meeting held in Philadelphia earlier this month. Read more »

It’s no secret that industry pipelines are thin at the moment. But what about innovations in pharmaceutical science? Are companies keeping up with the times to develop new ways of testing, delivering, formulating, analyzing, or manufacturing drugs? Pharmaceutical Technology would like to hear from you. In fact, we launched a call for nominations for the 2008 Innovations in Pharma Science Awards earlier this summer. The awards will honor achievements in the pharmaceutical sciences, specifically in these five areas:

1) Drug delivery (solid dosage and parenteral forms)
2) Formulation development (solid dosage and parenteral forms)
3) Dosage-form manufacturing (solid dosage and parenteral forms)
4) Pharmaceutical analysis
5) API synthesis and manufacturing (small molecules and biologics).

But the deadline for nominations is here. Check out this link to nominate your company’s work in one of five areas by next week. The winners will be announced in the December issue.